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Spotlight Series on Hepatitis C

"Ask the Experts": What Are the Different Phases of Hepatitis C Clinical Trials?

The following is a physician-patient interaction that took place within TheBody.com's "Ask the Experts" forum on hepatitis.

hepatitis c study phases
Apr 13, 2013

What is the difference between phase 1, phase 2, and phase 3 studies since all the newer drugs are being tested in these type of studies?

Response from Dr. Taylor

New hepatitis C pills are under investigation. In a clinical trial, new methods to better our health are tested in people who volunteer to participate in a research study.

For studies that test new medicines, in general, there are 3 types, or phases. Phase 1 trials consider safety such as the safe doses of a new drug and side effects. Phase 2 trials come after Phase 1 trials, after basic safety looks good. (Some drugs do not make it past Phase 1.) People with a disease, in this case hepatitis C, get the medication under study. Researchers evaluate how well the medication treats hepatitis C, and what the side effects are in people with the disease. Finally in Phase 3 trials, the new medication is compared to the established treatment, in terms of how effective and safe it is.

Return to our full listing of answers to patients' frequently asked questions regarding hepatitis C transmission, testing, management and treatment.





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